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510(k) K912997

MINIFLEX AND PERSONAL UNIT by Dabi-Atlante America Corp. — Product Code EAZ

K912997 is an FDA 510(k) premarket notification submitted by Dabi-Atlante America Corp. for the device "MINIFLEX AND PERSONAL UNIT". The FDA issued a decision of Substantially Equivalent on October 30, 1991. The device falls under product code EAZ (Light, Operating, Dental), a Class I device regulated under 21 CFR 872.4630. Dabi-Atlante America Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1991
Date Received
July 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Operating, Dental
Device Class
Class I
Regulation Number
872.4630
Review Panel
DE
Submission Type

Other clearances by Dabi-Atlante America Corp.

  • K926155 — CA AND ST (March 4, 1994)
  • K926154 — HANDPIECE MODELS: MS-350;RS-350;N-270 AIR-MOTOR (March 4, 1994)
  • K922437 — HANDPIECE MODELS MS-350, RS-350; AIR MOTOR N-270 (December 21, 1992)

Other clearances for product code EAZ

  • K072309 — MICROLUX/BLU (November 19, 2007)
  • K041614 — MICROLUX DL (April 4, 2005)
  • K033033 — VIZILITE-BLUE ORAL EXAM KIT (November 22, 2004)
  • K003995 — SPECULITE/ORALLITE (March 16, 2001)
  • K926081 — DENTAL LIGHT (January 26, 1994)
  • K935390 — SIROLUX FANTASTIC (December 10, 1993)
  • K925629 — ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT (November 23, 1993)
  • K923462 — DELIGHT (December 21, 1992)
  • K912142 — MICRONAIRE ISO-HOOD MAX 5UV (October 30, 1991)
  • K902685 — DEFIANCE MODEL FUS 336 (September 17, 1990)

FDA data resources